Cleared Traditional

K001997 - WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)

K001997 is an FDA 510(k) clearance for WHITE KNIGHT BLUE, manufactured by White Knight Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K001997 · White Knight Healthcare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
276d
Days
Class 2
Risk

K001997 is an FDA 510(k) clearance for the WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by White Knight Healthcare, Inc. (New Port Riche, US). The FDA issued a Cleared decision on April 2, 2001 after a review of 276 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all White Knight Healthcare, Inc. devices

FDA 510(k) Submission Details - K001997

510(k) Number K001997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2000
Decision Date April 02, 2001
Days to Decision 276 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 129d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 529
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K001997.
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · Primeline Medical Products, Inc. · Jun 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · White Knight Healthcare, Inc. · Apr 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · White Knight Healthcare, Inc. · Apr 2001
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
K001951 · Primeline Medical Products, Inc. · Sep 2000
HENRY SCHEIN SURGICAL MASK
K992604 · Mitsui Textile Corp. · Jan 2000
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999